Brain Enhancement Training for Age-Related Cognitive Decline

(BETTER Aging Trial)

Recruiting at 1 trial location

Overseen By Michelle Voss, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Posit Science Corporation

Disqualifiers: Dementia, Severe visual deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 53

180 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a brain training program that you can do online. It aims to help older adults improve their brain function by making their brains practice different tasks. The study includes both people who have done the training before and new participants.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How is the treatment PACR-CT different from other treatments for age-related cognitive decline?

PACR-CT, or Brain Enhancement Training, is unique because it focuses on enhancing brain function through specific training exercises, rather than relying on medication or physical interventions. This approach may offer a novel way to address cognitive decline by potentially improving brain structure and function through targeted activities. ^{1 2 3 4 5}

Research Team

Hyun Kyu Lee, PhD

Principal Investigator

Posit Science Corporation

Eligibility Criteria

This trial is for people aged 70 or older who speak English fluently, can see and hear well enough to use a computer, and can control a mouse. They must not have dementia as shown by the MoCA test. Those with severe visual/hearing deficits, recent cognitive training, suicidal thoughts, certain medical conditions or implants that interfere with MRI cannot join.

Inclusion Criteria

Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)

I am 70 years old or older.

I am fluent in English.

Exclusion Criteria

Participant with claustrophobia or any other contraindication to MRI scanning

Participant with recent participation of computer-delivered cognitive training within 2 years of consent

I cannot stay still for an MRI that lasts 1 hour.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Pre-training

Cognitive and functional assessments, MRI/fMRI, and blood draw for all participants

1 visit

1 visit (in-person)

Training

Participants undergo 10 weeks of computerized plasticity-based adaptive cognitive training

10 weeks

Up to 50 sessions, 5 sessions per week

Post-training

Cognitive and functional assessments and MRI/fMRI after training

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for changes in life satisfaction, sleep, functional abilities, diet, and other outcomes

5 years

Treatment Details

Interventions

• PACR-CT

Trial Overview The study tests a web-based brain training program (PACR-CT) on elders to see if it helps their cognition five years after initial training and examines the effects of an additional 10 weeks of booster training. The software poses no significant risk.

Participant Groups

Group I: Experimental Treatment Experimental Treatment 1 Intervention

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.

Who Is Running the Clinical Trial?

Posit Science Corporation

Lead Sponsor

Trials

40

Recruited

4,400+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

The University of Texas at Dallas

Collaborator

Trials

71

Recruited

108,000+

Findings from Research

A study involving 299 individuals, including 73 normal older adults and 91 with mild Alzheimer's disease, found that white matter (WM) volume declines with age, particularly in specific brain regions associated with cognitive function.

The research revealed that Alzheimer's disease is linked to further reductions in WM volume, especially in areas like the parahippocampal and entorhinal regions, highlighting the potential role of WM degeneration in cognitive decline related to aging and Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional white matter volume differences in nondemented aging and Alzheimer's disease. Salat, DH., Greve, DN., Pacheco, JL., et al.[2022]

Neuroimaging studies show that the oldest-old (85 years and older) exhibit greater brain atrophy and a higher burden of white matter lesions compared to younger elderly individuals, which are linked to dementia and cognitive impairment.

Despite a high amyloid burden in the oldest-old, it remains a significant predictor of cognitive decline, especially when combined with other neuroimaging indicators like atrophy and white matter lesions, emphasizing the need for more research in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging in the Oldest-Old: A Review of the Literature. Woodworth, DC., Scambray, KA., Corrada, MM., et al.[2021]

Nearly 50% of elderly individuals with mild cognitive impairment (MCI) develop Alzheimer's-type dementia (DAT) within 5 years, highlighting the importance of early detection.

Magnetization transfer ratio (MTR) measurements in gray matter were significantly lower in both MCI and DAT groups compared to healthy controls, suggesting that MTR could serve as a novel MRI biomarker for early diagnosis of Alzheimer's dementia, even before significant volumetric changes are observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetization transfer ratio in mild cognitive impairment and dementia of Alzheimer's type. Kabani, NJ., Sled, JG., Chertkow, H.[2006]

In a study of 18 patients with probable Alzheimer's dementia, significant cognitive decline was correlated with reductions in brain perfusion and cortical volume, highlighting the relationship between brain structure changes and cognitive function.

Patients showed annual rates of ventricular volume enlargement and cortical atrophy, with cognitive tests indicating declines in scores, while age-matched controls exhibited no cognitive changes, suggesting that these CT changes are specific to dementia progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive declines correlate with decreased cortical volume and perfusion in dementia of Alzheimer type. Obara, K., Meyer, JS., Mortel, KF., et al.[2019]

In a study of 40 healthy elderly participants, MRI scans revealed that atrophy of the hippocampus and amygdala (HA) is linked to poorer memory performance, indicating a potential marker for cognitive decline.

Unlike HA atrophy, the presence of deep white matter lesions (DWML) and periventricular lesions (PVL) did not correlate with memory impairment, suggesting that HA atrophy may be a more specific indicator of cognitive issues in aging individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging correlates of memory impairment in the healthy elderly: association with medial temporal lobe atrophy but not white matter lesions. O'Brien, JT., Desmond, P., Ames, D., et al.[2006]

References

1. United States pubmed.ncbi.nlm.nih.gov

Regional white matter volume differences in nondemented aging and Alzheimer's disease. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroimaging in the Oldest-Old: A Review of the Literature. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Magnetization transfer ratio in mild cognitive impairment and dementia of Alzheimer's type. [2006]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive declines correlate with decreased cortical volume and perfusion in dementia of Alzheimer type. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging correlates of memory impairment in the healthy elderly: association with medial temporal lobe atrophy but not white matter lesions. [2006]